Status:
RECRUITING
Post-Marketing Surveillance of Vliwazell® Prowound Dressing
Lead Sponsor:
Lohmann & Rauscher
Conditions:
Acute and Chronic Wounds
Eligibility:
All Genders
18+ years
Brief Summary
This PMCF study is conducted to confirm the effectiveness and safety of the wound dressing Vliwazell® Pro. The aim of the study is to validate the performance of Vliwazell® Pro within its intended pur...
Detailed Description
Vliwazell® Pro is a flexible and soft superabsorbent wound dressing designed for acute and chronic wounds with moderate to very high levels of exudate (wound fluid). The inner non-woven layer helps ev...
Eligibility Criteria
Inclusion
- Wound according to indication mentioned in the instructions for use:
- Superficial acute and chronic wounds with moderate to very high amounts of exudate and that are superficial, in:
- arterial and venous ulcers
- diabetic ulcers
- pressure ulcers
- post-traumatic wounds
- post-operative wounds healing by secondary intention
- skin graft donor sites
- oncological wounds
- ulcerating tumors
- wounds at risk of infection
- superficial 2nd degree burns
- lymphatic wounds
- As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used with appropriate wound filler
- Patient has full legal capacity
- Patient is able to understand and provide information
- Patient has signed the written Informed Consent Form
Exclusion
- Age \< 18 years
- Patient with contraindication:
- Known allergy and/or hypersensitivity to any of the product components.
- Not for use in tunnel-forming wound pockets, as the product may expand considerably with the absorption of wound exudate.
- Not for use on dry wounds.
- Pregnant or lactating women
- Patients participating in another clinical trial at the time of inclusion
- Patient not covered by health insurance/social security
Key Trial Info
Start Date :
March 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT07316556
Start Date
March 11 2024
End Date
January 31 2027
Last Update
January 5 2026
Active Locations (8)
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1
Wundmanagement
Aachen, Germany
2
MVZ Hausärzte
Brüggen, Germany
3
ORGAMed
Dortmund, Germany
4
Hautklinik
Erlangen, Germany